Is Melatonin legal in Italy?

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A flag of Italy, next to the chemical structure of Melatonin

Formal status

No EU-wide rule governs melatonin in food supplements; each member state decides independently, and the resulting positions vary widely.

Italy permits melatonin in food supplements up to 1 mg per day. The Ministry of Health set this ceiling by circular in 2013, reducing it from 5 mg to align with the EFSA-assessed dose supporting the authorised sleep-onset claim and to demarcate supplement use from the 2 mg prolonged-release melatonin medicines authorised in the EU. Above 1 mg per day the product falls to be treated as a medicine. Melatonin appears in the Ministry's "other substances" table with that intake limit, so a compliant supplement route is fully available - entirely separate from the cannabinoid prohibitions affecting the rest of the formula.

Do we sell here?

Not at the moment.

Melatonin is not the reason we don't sell 01 Sleep in Italy - our 1mg dose sits inside Italy's 1mg supplement ceiling, with no grey area. The product is unavailable there because of its CBD and CBN content.

Outlook

Italy's 1 mg ceiling has been stable since 2013 with no indication of movement. Given the reason it was set, described above, any future change would most likely follow EU-level harmonisation rather than an Italian initiative.

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The Ministry of Health cuts the maximum melatonin content of food supplements from 5 mg to 1 mg per day, effective 30 September 2013, to align with the EFSA-assessed claim dose and to demarcate supplements from 2 mg melatonin medicines.

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